FDA Seeks To Tame Exploding Medical App Market

Want to monitor your blood pressure and sugar level? Eat
healthier meals? Screen yourself for depression? Find out if you
need glasses? Now you can do it all with apps on your
smartphone.

In fact, there are 40,000 medical applications available for
download on smartphones and tablets—and the market is still
in its infancy. But that growth is in the crosshairs of new
regulatory efforts from the Food and Drug Administration.

Medical apps offer the opportunity to monitor health and
encourage patient wellness on a moment-to-moment basis, instead of
only during the occasional visit to the doctor's office. Some even
replace devices used in hospitals and doctors' offices, such as
glucometers and the high-quality microscopes used by dermatologists
to examine skin irregularities.

"There's a lot of enthusiasm now about for the ability to use
design and to use consumer technology to help improve people's
health at the ground level," says Andrew Rosenthal, who works for
Massive Health, a mobile health app company in San Francisco.

But so far, the market has been something of an unregulated Wild
West; for doctors and patients alike, it is difficult to know which
apps actually live up to their health claims or provide accurate
information.

Last year, the FDA began to lay down the law. The agency
released a first draft of guidelines that require mobile apps
developers making medical claims to apply for FDA approval for
those applications, the same way that new medical devices must be
proven safe and effective before they can be sold. But that process
can be both time consuming and expensive.

Some app developers are bristling at the thought of a rigid
regulatory structure, which they fear will stifle innovation in an
industry known for rapid growth and flexibility.

"The FDA's current regulatory process was created when the
floppy disk was around" -- ancient history in the tech world, warns
Joel White, executive director of the Health IT Now Coalition,
which includes the computer chip maker Intel, pharmacy benefit
manager Medco, Verizon, Aetna and the U.S. Chamber of Commerce.

According to the Government Accountability Office, , the FDA takes
about six months to approve a medical device that is similar to an
existing product and 20 months to approve a brand new device.
That’s simply too slow, says White.

"We're seeing mobile apps updated and created on a daily basis,"
he explains. "The lifecycle is dramatically different."

It's also expensive: the cost of getting FDA approval for a
standard medical device is about $24 million to $75 million,
according to a Stanford University report.

The health app market currently is worth about $718 million and
is expected to double by the end of the year, according to
Research2Guidance, a global mobile research
group.

Protecting Consumers

Alain Labrique, who directs a global project at Johns Hopkins
University dedicated to mobile health technology, says that
although the FDA guidelines could delay some tech development, they
are an important consumer safeguard.

Labrique argues that many apps are "a lot of hype and very
little evidence." While apps offer an exciting new opportunity in
health care, "we also want to protect the public and be sure that
medical claims are supported by data assessment and some comparison
to a gold standard."

In particular, he warns that commercial interests and "the
tendency to capitalize on the next big things" may lead app
developers to overstate what their products can accomplish. "Making
sure the public’s best interests are met is not always the
most expedient process."

The FDA expects to release final guidelines on mobile health
apps this year, but some app developers aren’t waiting. Many
companies have started the formal application process, and the FDA
has already approved a handful of apps.

White says that many app developers are not opposed to
regulation, but they believe that the FDA process doesn’t fit
the industry. He suggested that the government set up a new
regulatory framework for mobile health—something like the
Transportation Safety Board—to accommodate the speed,
flexibility and innovation of this new marketplace.

Dr. Orrin Franko, 29, is part of a new breed of
doctor-innovators in the mobile health industry. He’s an
orthopedic surgery resident at the University of California San
Diego and runs a website called TopOrthoApps.com, where he reviews
orthopedic apps for doctors and patients. He is also busily
developing several of his own.

Dr. Orrin Franko
Recently, he invented a plastic attachment that works with an app
that allows iPhones to measure the curve of the spine to test for
scoliosis. It mimics a medical device called a Scioliometer, which
is used in nearly every hospital across the country. The
Scoliometer costs about $100 and was cleared by the FDA in 1983;
the iPhone app costs iPhone app costs $0.99.99,, and Franko says his
plastic attachment could be sold for about $10.

But he also knows that his device will have to be approved by
the FDA, requiring a significant capital investment. He's planning
to apply, he says, but with so many new apps coming on the market
"there's no way the FDA is going to keep up."

Instead, he predicts, app developers with products that are not
strictly medical, such as a healthy eating app, may avoid making
medical claims in their marketing in order to skip the FDA process
and will rely on good user reviews instead to generate
publicity.

While the FDA sorts the process out with developers, Franko
isn't wasting any time. In January, he helped launch the
peer-reviewed Journal of Mobile Technology in Medicine to help
doctors make sense of the bonanza of medical apps.

Franko's goal is to make sure doctors and patients know what
they're getting as quickly as possible. "These apps already exist,"
he explains, "and people are using them in hospitals to make
medical decisions, but no one knows if they’re actually doing
what they’re claim to be doing."

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